R Street calls on Congress to amend FDA rules for e-cigarettes

WASHINGTON (May 5, 2016) – The R Street Institute expressed deep disappointment with the Food and Drug Administration’s final rule, published today, calling for all electronic cigarette products introduced to market after February 2007 to undergo a costly and complicated review process.

Left unchanged, the rule will affect virtually all e-cigarette and vapor products currently on the market, potentially denying access to millions of consumers who seek a safer alternative to tobacco products.

“Since virtually all e-cigarette and vapor products entered the market after February 2007, if the FDA’s current approach is implemented, producers would be required to submit expensive and burdensome applications for each and every product and given just two years to comply,” R Street Policy Analyst Caroline Kitchens said. “In order to preserve this growing market and allow continued innovation in the vapor-product industry, it’s essential that Congress act to amend the grandfather date set out in the 2009 FDA Tobacco Law.”

The Fiscal Year 2017 House Agriculture Appropriations bill contains language that would move the predicate date until the effective date of the final regulations, likely to be later this year. Under an amendment to the bill sponsored by Reps. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., consumers could continue to use these products.

“The House should pass this important bill and the Senate should follow suit. If the measure remains mired in the appropriations process, we would urge Congress should find a different legislative vehicle to achieve these goals, such as the standalone legislation H.R. 2058,” Kitchens said. “If Congress doesn’t act, millions of consumers across the country will be denied the option to use these safer alternatives.”

E-cigarettes have been shown through research to present less than 5 percent of the health risks posed by tobacco and are relied upon by thousands of Americans as a tool to help them quit smoking.

“From the perspective of both public health and basic logic, we should do everything we can to steer smokers away from combustible tobacco and toward lower-risk alternatives – not enforce an arbitrary regulatory regime that privileges the deadliest forms of nicotine delivery,” Kitchens added.

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